Mechanical Design Engineer

Capgemini

Opfikon

Hybrid

CHF 110,000 - 140,000

Full time

8 days ago

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Benefits offered by this job

5 weeks vacation
Employee referral bonus
Company shares program
Annual fitness subscription

Job summary

Capgemini Engineering seeks an experienced Mechanical Design Engineer to design, develop, and implement custom tooling and equipment for aseptic fill & finish operations within an isolator environment. You will ensure First Air protection and Annex 1 compliance while improving operator safety and process robustness.

Responsibilities include creating 3D CAD models and drawings in SolidWorks, performing design reviews and risk assessments, supporting FAT/SAT and commissioning, and collaborating

Qualifications

  • Bachelor's or Master's degree in Mechanical Engineering, Mechatronics, or related field.
  • Several years of experience in machine design, special-purpose machinery, pharmaceutical equipment, or aseptic manufacturing environments.
  • Strong CAD skills (SolidWorks or equivalent).
  • Experience creating manufacturing drawings and technical documentation.
  • Understanding of mechanical design, materials, tolerances, and fabrication methods.
  • Ability to work independently in multidisciplinary project teams.
  • Experience with pharmaceutical fill & finish equipment is a plus.
  • Knowledge of isolator technology and aseptic processing is a plus.

Responsibilities

  • Design and develop custom isolator tools, fixtures, change parts, and operator aids for aseptic fill & finish operations.
  • Ensure designs comply with Annex 1 principles and maintain protection of critical zones and First Air.
  • Create and review 3D CAD models, assemblies, drawings, and technical documentation.
  • Perform design reviews, risk assessments, and feasibility studies.
  • Evaluate operator interventions and develop engineering controls to minimize contamination risks.
  • Support FAT, SAT, commissioning, and implementation activities.
  • Collaborate with equipment suppliers and engineering partners during development and procurement phases.
  • Apply hygienic design principles and GMP requirements throughout the design lifecycle.

Skills

Problem-solving mindset
Independent work in multidisciplinary,

Education

Bachelor's or Master's in Mechanical Engineering/Mechatronics

Tools

SolidWorks

Job description

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.YOUR ROLEWe are seeking an experienced Mechanical Design Engineer to support the design, development, and implementation of custom tooling and equipment for aseptic fill & finish operations within an isolator environment. The role focuses on developing solutions that maintain First Air protection, support Annex 1 compliance, and improve operator safety, ergonomics, and process robustness.The successful candidate will work closely with Process Engineering, Manufacturing, Automation, Validation, Quality, and external equipment suppliers.Your ResponsibilitiesDesign and develop custom isolator tools, fixtures, change parts, and operator aids for aseptic fill & finish operations.Ensure designs comply with Annex 1 principles and maintain protection of critical zones and First Air.Create and review 3D CAD models, assemblies, drawings, and technical documentation.Perform design reviews, risk assessments, and feasibility studies.Evaluate operator interventions and develop engineering controls to minimize contamination risks.Support FAT, SAT, commissioning, and implementation activities.Collaborate with equipment suppliers and engineering partners during development and procurement phases.Apply hygienic design principles and GMP requirements throughout the design lifecycle.Support continuous improvement initiatives for isolator operations and aseptic processes.YOUR SKILLS AND EXPERIENCEBachelor's or Master's degree in Mechanical Engineering, Mechatronics, or a related engineering discipline.Several years of experience in machine design, special-purpose machinery, pharmaceutical equipment, or aseptic manufacturing environments.Strong CAD skills (SolidWorks or equivalent).Experience creating manufacturing drawings and technical documentation.Understanding of mechanical design, materials, tolerances, and fabrication methods.Ability to work independently in multidisciplinary project teams.Preferred QualificationsExperience with pharmaceutical fill & finish equipment.Knowledge of isolator technology and aseptic processing.Understanding of EU GMP Annex 1 requirements.Experience with airflow concepts, contamination control, and First Air protection.Experience supporting qualification and validation activities in GMP environments.Familiarity with ergonomic design and human-machine interactions within isolators.Key CompetenciesStrong engineering judgementProblem-solving mindsetRisk-based decision makingExcellent communication skillsAbility to challenge designs from a contamination control perspectiveHands-on approach during testing and implementationWHAT YOU’LL LOVE ABOUT WORKING HERE?At our engineering academy, you’ll have access to over 60,000 hours of world-class training - designed to fuel your growth from day one. Whether you're diving into Generative AI, data science, or sustainability, our digital campus supports your learning journey every step of the way;Experience the benefits of hybrid working, offering flexibility and ensuring work-life balance;Harness the strength of diverse teams, fostering innovation and inclusive collaboration;We offer additional benefits such as 5 weeks of vacation, Employee referral bonus, Company shares program and Annual contribution to a fitness subscription.Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.
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